Pegfilgrastim as Support to Pediatric Sarcoma Patients Receiving Chemotherapy - Full Text View

Sponsor:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00035620

Purpose

Physicians are conducting a clinical trial for patients with pediatric sarcoma. Sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. Neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. If the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. Neutropenia is serious because it can affect the body's ability to protect against many types of infections. Pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. The purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.

Condition	Intervention	Phase
Sarcoma Neutropenia	Drug: pegfilgrastim Drug: filgrastim	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Study of Single Dose Per Cycle Filgrastim-SD/01 as an Adjunct to VAdriaC/IE Chemotherapy in Pediatric Sarcoma Patients

Resource links provided by NLM:

Genetics Home Reference related topics: cyclic neutropenia

MedlinePlus related topics: Bone Cancer Cancer Soft Tissue Sarcoma

Drug Information available for: Filgrastim Lenograstim Granulocyte colony-stimulating factor Pegfilgrastim

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Duration of severe neutropenia in chemotherapy in cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]
Time to ANC recovery to greater than or equal to 0.5 x 10^9/L in cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetic profile in chemotherapy cycles 1 and 3 [ Time Frame: cycles 1 and 3 ] [ Designated as safety issue: No ]
Incidence of adverse events across all cycles of chemotherapy [ Time Frame: all cycles ] [ Designated as safety issue: Yes ]
Overall rates of febrile neutropenia [ Time Frame: all cycles ] [ Designated as safety issue: No ]

Enrollment:	44
Study Start Date:	April 2000
Study Completion Date:	April 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Filgrastim Filgrastim	Drug: filgrastim filgrastim Other Name: filgrastim
Experimental: Pegfilgrastim Pegfilgrastim	Drug: pegfilgrastim pegfilgrastim

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Sarcoma * No previous chemotherapy or radiotherapy * Patients who will be receiving chemotherapy consisting of Vincristine, Doxorubicin, Cyclophosphamide, Etoposide, Ifosfamide, and Mesna

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00035620

Sponsors and Collaborators

Amgen

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

To access clinical trial results information click on this link This link exits the ClinicalTrials.gov site

FDA-approved Drug Labeling This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00035620 History of Changes
Other Study ID Numbers:	990130
Study First Received:	May 3, 2002
Last Updated:	February 25, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Amgen:

Bone cancer
Sarcoma
Neutropenia
Chemotherapy

Additional relevant MeSH terms:

Neutropenia
Sarcoma
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type
Neoplasms
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012